Senior Clinical Trials Manager

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Jazz Pharmaceuticals Development Operations team. The Clinical Trials Manager responsibilities include (but are not limited to) the following:

Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.

Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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VIEW JOBS11/9/2018 12:00:00 AM2019-02-07T00:00This position will report to the Principal Investigator at our Pennsylvania Hospital disease site and will also work closely with the Lead Nurse for the group, if one has been designated. The successful candidate will work closely with disease group investigators to oversee all aspects of the research being performed within their group. This includes assisting with study selection, prioritization of the team's work, working closely with the Regulatory Manager to manage, review and initiate trials. Project Managers are expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing patient visits, transporting specimens, data entry, query resolution and working with study monitors).
Specific responsibilities include (but are not limited to):
* Working with disease site physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources, anticipate any need for a disease group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
* Submitting complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts
* Performing group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572's and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
* Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed
* Work closely with the Regulatory Manager of the CRU to manage review and startup of trials
* Working with team members to ensure accurate and timely data entry into Velos (our electronic Clinical Trials Management System), including study status, screening logs, serious adverse events and subject enrollment status
* Closely monitoring and reporting to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues
* Conducting weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed
* Monitoring staff workload and work with other disease teams and Administrative Director to share or borrow staff when needed and appropriate. This will include management of staff paid time off.
* Attending disease group meetings, site initiation visits, and (as needed) monitoring visits.
This position is located at our Pennsylvania Hospital disease site.
Position is contingent on continued funding. CC-Cancer CenterUniversity Of PennsylvaniaPhiladelphiaPA

VIEW JOBS12/4/2018 12:00:00 AM2019-03-04T00:00Senior Clinical Trial Support Specialist
* Philadelphia, PA
* Full Time
* Clinical Operations
* Senior Manager/Supervisor
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Job Summary
The Senior Clinical Trial Support Specialist will conduct and facilitate activities associated with start-up activities including preparation of site submission packages, interaction with sites to ensure all required documents are in place for site activation, in accordance with relevant regulations, SOPs, and study specific procedure.
In addition, the senior CTSS will provide support for other activities such as site qualification, monitoring and clinical study report writing.
Responsibilities and Duties
* Study Start up
* Support site pre-qualification
* Assign site and PI numbers
* Review and validate site identification list
* Follow up with site on ethics submission and approval received (initial submission and amendments)
* Review feedback/comments from sites on the ICF to ensure compliance with ADAP requirements; resolve changes requested by the site and approve with support from Clinical Team, safety and legal.
* Prepare, collect and negotiate Confidentially Agreements (CDA) as required. Resolve CSA changes requested by the site and approve any change in CSA language with support from Clinical Team and Legal; Collect internal CSA signatures
* Interface with internal TMF group to ensure site submission package is sent and start up documents are submitted to TMF
* Study Conduct
* Manage SAE email distribution
* Ensure good understanding of project scope, milestones, budgets to confirm payment of invoices
* Submit relevant documents to the Trial Master File
* Create and maintain Study Procedures Manual and ICF as needed
* General Clinical Operations Support
* Liaise with other internal departments to avoid duplication of effort across studies around completion of forms (eg, IBC forms), vendor form updates, etc.
* Manage the SNAP (subject number assignment program) across studies; Maintain relevant SOP
* Proactively keep clinical scientists and manager informed about work progress and any issues (including conflicting priorities and free capacity)
* Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Adaptimmune SOPs, other Adaptimmune training requirements, and study specific procedures and training
* Escalate any issues that require immediate action to the clinical scientist
* Proactively work with team members to meet project goals
* Support metric tracking and protocol deviation quarterly review
* Other Operational Aspects
* Contribute to trip reports when in attendance and participating at the site
* Support monitoring visits as needed
* Support medical writing activities
Qualifications and Skills
* Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
* At least 2 years relevant pharmaceutical experience
* Client focused approach to work
* Ability to manage multiple and varied tasks with enthusiasm
* Attention to detail
* Strong interpersonal, verbal, and written communication skills (both spoken and written) – with ability to effectively communicate on project planning, progress, tracking etc
* Fluent in local office language and in English, both written and verbal
* Strong relationship building skills to work effectively with others in various disciplines and levels
* Sense of urgency and follow through in completing assigned tasks
* Effective time management in order to meet daily metrics, team objectives, and department goals
* Good presentation skills
* Excellent communication skills
* Highly motivated, independent and a self-starter
* Valid driver's license
* Ability to travel internationally (valid passport).
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Adaptimmune Therapeutics PlcPhiladelphiaPA

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